TY - JOUR
T1 - Clinical outcomes during anticoagulant therapy in fragile patients with venous thromboembolism
AU - Moustafa, Farès
AU - Giorgi Pierfranceschi, Matteo
AU - Di Micco, Pierpaolo
AU - Bucherini, Eugenio
AU - Lorenzo, Alicia
AU - Villalobos, Aurora
AU - Nieto, José A.
AU - Valero, Beatriz
AU - Sampériz, Ángel L.
AU - Monreal, Manuel
AU - The RIETE Investigators
A2 - Decousus, Hervé
A2 - Prandoni, Paolo
A2 - Brenner, Benjamin
A2 - Barba, Raquel
A2 - Bertoletti, Laurent
A2 - Tzoran, Inna
A2 - Reis, Abilio
A2 - Bosevski, Marijan
A2 - Bounameaux, Henri
A2 - Malý, Radovan
A2 - Wells, Philip
A2 - Papadakis, Manolis
A2 - Adarraga, M. D.
A2 - Agudo, P.
A2 - Aibar, M. A.
A2 - Alfonso, M.
A2 - Arcelus, J. I.
A2 - Ballaz, A.
A2 - Barba, R.
A2 - Barrón, M.
A2 - Barrón-Andrés, B.
A2 - Bascuñana, J.
A2 - Blanco-Molina, A.
A2 - Cañas, I.
A2 - Casado, I.
A2 - Chic, N.
A2 - del Pozo, R.
A2 - del Toro, J.
A2 - Díaz-Pedroche, M. C.
A2 - Díaz-Peromingo, J. A.
A2 - Falgá, C.
A2 - Fernández-Aracil, C.
A2 - Fernández-Capitán, C.
A2 - Fidalgo, M. A.
A2 - Font, C.
A2 - Font, L.
A2 - Gallego, P.
A2 - García, M. A.
A2 - Skride, A.
A2 - Vitola, B.
N1 - Publisher Copyright:
© 2017 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals, Inc on behalf of International Society on Thrombosis and Haemostasis.
PY - 2017/10
Y1 - 2017/10
N2 - Essentials Recent randomized trials suggested fewer bleeding events in fragile patients with VTE receiving DOACs. The frequency, clinical characteristics and outcome of these patients have not been reported in real life. Fragile patients with VTE had a higher risk for major bleeding or death and a lower risk for recurrences than non-fragile. Background: Subgroup analyses from randomized trials suggested favorable results for the direct oral anticoagulants in fragile patients with venous thromboembolism (VTE). The frequency and natural history of fragile patients with VTE have not been studied yet. Objectives: To compare the clinical characteristics, treatment and outcomes during the first 3 months of anticoagulation in fragile vs non-fragile patients with VTE. Methods: Retrospective study using consecutive patients enrolled in the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry. Fragile patients were defined as those having age ≥75 years, creatinine clearance (CrCl) levels ≤50 mL/min, and/or body weight ≤50 kg. Results: From January 2013 to October 2016, 15 079 patients were recruited. Of these, 6260 (42%) were fragile: 37% were aged ≥75 years, 20% had CrCl levels ≤50 mL/min, and 3.6% weighed ≤50 kg. During the first 3 months of anticoagulant therapy, fragile patients had a lower risk of VTE recurrences (0.78% vs 1.4%; adjusted odds ratio [OR]: 0.52; 95% confidence intervals [CI]: 0.37-0.74) and a higher risk of major bleeding (2.6% vs 1.4%; adjusted OR: 1.41; 95% CI: 1.10-1.80), gastrointestinal bleeding (0.86% vs 0.35%; adjusted OR: 1.84; 95% CI: 1.16-2.92), haematoma (0.51% vs 0.07%; adjusted OR: 5.05; 95% CI: 2.05-12.4), all-cause death (9.2% vs 3.5%; adjusted OR: 2.02; 95% CI: 1.75-2.33), or fatal PE (0.85% vs 0.35%; adjusted OR: 1.77; 95% CI: 1.10-2.85) than the non-fragile. Conclusions: In real life, 42% of VTE patients were fragile. During anticoagulation, they had fewer VTE recurrences and more major bleeding events than the non-fragile.
AB - Essentials Recent randomized trials suggested fewer bleeding events in fragile patients with VTE receiving DOACs. The frequency, clinical characteristics and outcome of these patients have not been reported in real life. Fragile patients with VTE had a higher risk for major bleeding or death and a lower risk for recurrences than non-fragile. Background: Subgroup analyses from randomized trials suggested favorable results for the direct oral anticoagulants in fragile patients with venous thromboembolism (VTE). The frequency and natural history of fragile patients with VTE have not been studied yet. Objectives: To compare the clinical characteristics, treatment and outcomes during the first 3 months of anticoagulation in fragile vs non-fragile patients with VTE. Methods: Retrospective study using consecutive patients enrolled in the RIETE (Registro Informatizado Enfermedad TromboEmbolica) registry. Fragile patients were defined as those having age ≥75 years, creatinine clearance (CrCl) levels ≤50 mL/min, and/or body weight ≤50 kg. Results: From January 2013 to October 2016, 15 079 patients were recruited. Of these, 6260 (42%) were fragile: 37% were aged ≥75 years, 20% had CrCl levels ≤50 mL/min, and 3.6% weighed ≤50 kg. During the first 3 months of anticoagulant therapy, fragile patients had a lower risk of VTE recurrences (0.78% vs 1.4%; adjusted odds ratio [OR]: 0.52; 95% confidence intervals [CI]: 0.37-0.74) and a higher risk of major bleeding (2.6% vs 1.4%; adjusted OR: 1.41; 95% CI: 1.10-1.80), gastrointestinal bleeding (0.86% vs 0.35%; adjusted OR: 1.84; 95% CI: 1.16-2.92), haematoma (0.51% vs 0.07%; adjusted OR: 5.05; 95% CI: 2.05-12.4), all-cause death (9.2% vs 3.5%; adjusted OR: 2.02; 95% CI: 1.75-2.33), or fatal PE (0.85% vs 0.35%; adjusted OR: 1.77; 95% CI: 1.10-2.85) than the non-fragile. Conclusions: In real life, 42% of VTE patients were fragile. During anticoagulation, they had fewer VTE recurrences and more major bleeding events than the non-fragile.
KW - anticoagulants
KW - hemorrhage
KW - mortality
KW - recurrences
KW - venous thromboembolism
UR - http://www.scopus.com/inward/record.url?scp=85039047769&partnerID=8YFLogxK
U2 - 10.1002/rth2.12036
DO - 10.1002/rth2.12036
M3 - Article
AN - SCOPUS:85039047769
SN - 2475-0379
VL - 1
SP - 172
EP - 179
JO - Research and Practice in Thrombosis and Haemostasis
JF - Research and Practice in Thrombosis and Haemostasis
IS - 2
ER -